Early Screening of Breast Lesion Trial (Phase III Pivotal)

描述（由申请人提供）：这项修订后的试验（先前评分194）结合了3个NCI资助的光学乳腺癌组的经验和知识产权，并提出了一项早期检测癌症试验。除了罕见的治疗例外（他莫昔芬，赫赛汀），乳腺癌诊断后的长期阶段特异性死亡率在50年内没有明显变化。事实上，在美国，平均乳腺肿瘤在诊断时测量>2 cm。与传统的放射学智慧相比，微钙化和其他特征通常导致乳腺癌的亚毫米诊断，许多乳腺肿瘤（30%）仍然只能通过疼痛，分泌物和触诊发现，特别是在年轻，致密的乳房中。这留下了很大的改进空间。在NCI资助的工作中，PI联盟超越了所有目标，证实了早期乳腺癌/结肠癌是基于与病理学（细胞结构，血管生成）和功能（局部代谢）相关的特征进行光学检测的，并且可以纠正与年龄相关的变化。NCI资助的试验结果显示： R43临床试验快速通道的具体目标是：目标1：在FDA设计控制和软件要求下，减少生产对血管生成、细胞结构和代谢敏感的商业级非成像光谱乳腺扫描仪。如果该器械符合性能质量标准，则3年R44的目标是：目标1：将提交前初步试验扩展为NIH定义的FDA提交器械的III期关键试验，根据GLP标准，在3个中心招募至少500例患者，为期36个月，足以提交FDA，目标2：根据510（k）提交并获得FDA批准，临床或PMA状态在此资助下。该提案的目标是将特定的乳腺癌筛查设备通过FDA批准推向市场，正如申请人P.I.成功地将两种现有的光学技术推向市场。

DESCRIPTION (provided by applicant): This amended trial (prior score 194) combines the experience and intellectual property of 3 NCI-funded Optical Breast Cancer groups, and proposes an early-detection cancer trial. With rare treatment exceptions (Tamoxifen, Herceptin), the long-term stage-specific mortality after breast cancer diagnosis has not appreciably changed in 50 years. In fact, the average breast tumor measures >2 cm at diagnosis in the U.S. In contrast to conventional radiology wisdom that micro-calcifications and other features have routinely led to sub-millimeter diagnosis of breast cancer, many breast tumors (30%) are still only found by pain, discharge, and palpation, especially in the young, dense breast. This leaves large room for improvement. In NCI-funded work, consortium PI's exceeded all aims, confirmed that early breast/colon cancers are optically detectable based upon features correlated to pathology (cellularity, angiogenesis) and function (local metabolism), and that age-related changes can be corrected for. Results of NCI-funded trials showed: The specific aims of this Clinical Trial Fast-Track for R43 Aims are: Aim 1: To reduce to manufacture a commercial-grade non-imaging spectroscopic breast scanner, sensitive to angiogenesis, cellularity, and metabolism, under FDA-design control and software requirements. If this device meets performance specifications, then the 3-year R44 aims are: Aim 1: To expand the pre-submission Pilot Trial into a NIH- defined Phase III pivotal trial of the FDA-submitted device enrolling a statistically-justified minimum of 500 patients at 3 centers over 36 months under GLP standards, sufficient for FDA submission, and Aim 2: To submit and obtain FDA approval under 510(k) with clinicals or PMA status under this funding. The goal of this proposal is to bring a specific breast cancer screening device past FDA approval to market, just as applicant P.I. has successfully brought 2 prior optical technologies to approval and market.